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Treatment of Lambert-Eaton Syndrome With 3, 4-Diaminopyridine

18 Years
Open (Enrolling)
Lambert Eaton Myasthenic Syndrome

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Trial Information

Treatment of Lambert-Eaton Syndrome With 3, 4-Diaminopyridine

Patients with clinically-confirmed LEMS will receive 3, 4 DAP by mouth in slowly increasing
doses. Treatment will begin with 5 mg, three times a day and will increase by 50% every two
weeks to 10-15 mg, three to six times a day, as clinically needed, and if tolerated.
Patients will be monitored for strength and side effects via routine out-patient clinic
visits at initial intervals of 1 month, increasing to intervals of 6 months as permitted.
Subjects will be asked to temporarily stop study drug to determine if there is a return of
symptoms and need for continued treatment with 3, 4 DAP. Results of treatment and adverse
events will be reported to the FDA. Treatment will be continued indefinitely if a good
clinical response is achieved and side effects are tolerable.

Inclusion Criteria:

- Be 18 years or older, diagnosed with LEMS

- If female, have negative pregnancy test and if premenopausal, be willing to
practice an effective form of birth control during the study.

Exclusion Criteria:

- Is known to have a sensitivity to 3, 4 DAP

- Has a history of past or current seizures

- Has a history of past or current severe asthma

- Is believed by the investigator to be unable to comply with the protocol

- Unable to give informed consent

Type of Study:

Expanded Access

Study Design:


Principal Investigator

David Richman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Food and Drug Administration

Study ID:




Start Date:

January 2000

Completion Date:

June 2011

Related Keywords:

  • Lambert Eaton Myasthenic Syndrome
  • Lambert Eaton Myasthenic Syndrome
  • 3,4 DAP
  • 3,4 Diaminopyridine
  • Lambert-Eaton Myasthenic Syndrome



University of California, Davis Sacramento, California  95818